Země: Evropská unie
Jazyk: angličtina
Zdroj: EMA (European Medicines Agency)
Olaratumab
Eli Lilly Nederland B.V.
L01XC27
olaratumab
Antineoplastic agents
Sarcoma
Lartruvo is indicated in combination with doxorubicin for the treatment of adult patients with advanced soft tissue sarcoma who are not amenable to curative treatment with surgery or radiotherapy and who have not been previously treated with doxorubicin (see section 5.1).
Revision: 3
Withdrawn
2016-11-09
30 B. PACKAGE LEAFLET Medicinal product no longer authorised 31 PACKAGE LEAFLET: INFORMATION FOR THE USER LARTRUVO 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION olaratumab This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Lartruvo is and what it is used for 2. What you need to know before you are given Lartruvo 3. How you are given Lartruvo 4. Possible side effects 5. How to store Lartruvo 6. Contents of the pack and other information 1. WHAT LARTRUVO IS AND WHAT IT IS USED FOR Lartruvo contains the active substance olaratumab, which belongs to a group of medicines called monoclonal antibodies. Olaratumab recognises and attaches specifically to a protein known as platelet-derived growth factor receptor-α (PDGFR-α). PDGFR-α is found in large amounts on some cancer cells where it stimulates the cells to grow and divide. When olaratumab attaches to PDGFR-α it may prevent cancer cell growth and survival. Lartruvo is used in combination with another anti-cancer medicine called doxorubicin for the treatment of adults with advanced soft tissue sarcoma who have not been previously treated with doxorubicin. Soft tissue sarcoma is a cancer that starts in the soft tissues, such as the muscles, fat, cartilage and blood vessels. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN LARTRUVO _ _ YOU MUST NOT BE GIVEN LARTRUVO - if you are allergic to olaratumab or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS You should t Přečtěte si celý dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Lartruvo 10 mg/mL concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One mL of concentrate for solution for infusion contains 10 mg of olaratumab. Each 19 mL vial contains 190 mg of olaratumab. Each 50 mL vial contains 500 mg of olaratumab. Olaratumab is a human IgG1 monoclonal antibody produced in murine (NS0) cells by recombinant DNA technology. Excipient with known effect Each 19mL vial contains approximately 22 mg (1 mmol) sodium. Each 50 mL vial contains approximately 57 mg (2.5 mmol) sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate). The concentrate is clear to slightly opalescent and colourless to slightly yellow solution without visible particles. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lartruvo is indicated in combination with doxorubicin for the treatment of adult patients with advanced soft tissue sarcoma who are not amenable to curative treatment with surgery or radiotherapy and who have not been previously treated with doxorubicin (see section 5.1). _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Olaratumab therapy must be initiated and supervised by physicians experienced in oncology. Patients should be monitored during the infusion for signs and symptoms of infusion-related reactions (IRRs) in a setting with available resuscitation equipment (see section 4.4). Posology The recommended dose of olaratumab is 15 mg/kg administered by intravenous infusion on days 1 and 8 of each 3 week cycle until disease progression or unacceptable toxicity. Lartruvo is administered in combination with doxorubicin for up Přečtěte si celý dokument